Rosiglitazone

DEA Class; Rx

Common Brand Names; Avandia

Hypersensitivity to rosiglitazone

Diabetic ketoacidosis

Heart failure NYHA class III-IV

Active liver disease: do not start rosiglitazone if ALT >2.5 x ULN

• Increased LDL-cholesterol
• Increased HDL-cholesterol
• Increased total cholesterol
• Edema
• Hypertension
• Heart failure/congestive heart failure
• Myocardial ischemia
• Diarrhea
• Upper respiratory tract infection
• Accidental injury
• Anemia
• Back pain
• Fatigue
• Headache
• Hypoglycemia
• Myalgia
• Sinusitis
• Weight gain

Fluid retention, which may exacerbate or lead to heart failure, may occur; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk of other cardiovascular effects

If ALT >3 x ULN stop treatment; if 1.5-3 x normal, retest qWeek until normal or 3 x normal and need to discontinue

Not for use in diabetes mellitus type 1; mechanism requires presence of endogenous insulin; use with insulin may increase risk of heart failure; not recommended

Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin; dose-related edema and weight gain may occur

When used in combination with other hypoglycemic agents, a dose reduction of concomitant agent may be necessary to reduce risk of hypoglycemia

Associated with rare cases of new onset or worsening of macular edema

May result in ovulation in some premenopausal anovulatory women; ensure adequate contraception

Increased risk of fractures of upper arm, hand, or foot in female patients

Dose-related decreases in hemoglobin and hemocrit reported

Limited data in pregnant women are not sufficient to determine drug- associated risk for major birth defects or miscarriage

There are no data on presence of rosiglitazone in human milk, effects on breastfed infant, or on milk production